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NCT05967130 Clinical Trial

Treatment Chronic UTI Post Kidney Transplant

Urinary Tract Infections Clinical Trial

Official title:
Treatment of Chronic Relapsing Urinary Tract Infection With Bacteriophages in Renal Transplant Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05967130
Other study ID # SBMU-
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2023
Est. completion date July 1, 2027

Study information
Verified date May 2024
Source Shahid Beheshti University of Medical Sciences
Contact Dalili
Phone 00989122404331
Email dr.nooshindalili@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Urinary tract infections (UTIs) with extended-spectrum -lactamase (ESBL)-positive Enterobacteriums (ESBL-E) are a common infectious complication of renal transplant recipients, with 10% of patients suffering from UTIs with ESBL-E within the first year posttransplant. Moreover, recurrence rates of UTI caused by ESBL-E are almost three times higher than those by cephalosporin-susceptible Enterobacteriums demonstrating the decreased efficacy of antibiotics in the treatment of these UTIs.

Description:

According to each patient's urine culture, resistant urinary tract infections will be treated with specific phages and patients will be followed up with their urine cultures for response to therapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date July 1, 2027
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Stable Kidney Transplant Recipients - Stable Immunosupression Dose - Stable Renal Function - Resistant Urinary Infection with Positive UC Exclusion Criteria: - Rejection periods - Frail Patients

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Phage
Inserting specific specimen of phages in to the bladder

Locations
Country Name City State
Iran, Islamic Republic of Nooshin Dalili Tehran

Sponsors (1)
Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine culture Negative Urine Culture 1 week after administration
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